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NCT Number: NCT04908696

Clinical Treatments in Specialized Diseases of Laryngeal Carcinoma (LC) and Hypopharyngeal Carcinoma (HPC)

For early stage laryngeal carcinoma and hypohparyngeal carcinoma (T1 and T2), transoral laser microsurgery, open partial laryngectomy, radiotherapy, and transoral robotic surgery were performed according to NCCN guidelines (2020).

For advanced stage laryngeal carcinoma and hypohparyngeal carcinoma (T3 and T4), surgical treatment ± postoperative adjuvant therapy, chemoradiotherapy, neoadjuvant therapy + radiotherapy/chemoradiotherapy, or neoadjuvant therapy + surgery + radiotherapy or chemoradiotherapy performed according to NCCN guidelines (2020).

This study plan to analyze the clinical ouctomes of different treatment for the same T stage disease. The overall survival rate, disease specific survival, disease free survival, local control, regional control, and laryngeal function preservation rate were analyzed in this study.

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Key information

About this study

For early stage laryngeal carcinoma and hypohparyngeal carcinoma (T1 and T2), transoral laser microsurgery (CO2 laser resection), open partial laryngectomy (vertical partial laryngectomy, cricohyoidoepiglottopexy, cricohyoidopexy, horizontal partial laryngectomy), partial hypopharyngectomy, radiotherapy, and transoral robotic surgery were performed for patients with proper indications.

For advanced stage laryngeal carcinoma and hypohparyngeal carcinoma (T3 and T4), surgical treatment ± postoperative adjuvant therapy, concurrent chemoradiotherapy, neoadjuvant therapy + radiotherapy/chemoradiotherapy, or neoadjuvant therapy + surgery + radiotherapy or chemoradiotherapy were performed for patients with proper indications.

This study seek to analyze and compare the clinical ouctomes of different treatments for the same T stage disease of LC and HPC.

The main end events involving overall survival rate, disease specific survival rate, and laryngeal function preservation rate were analyzed in this study. Beside, the events of disease free survival rate, local control rate, and regional control rate were assessed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Laryngeal cancer: glottic type, supraglottic type, and subglottic type; hypopharyngeal cancer: pyriform sinus type, postcri-coid type, and posterior pharyngeal wall type.
  • T1, T2, T3, and T4 stage.
  • Age 18 - 90.
  • Male or female.
  • Good compliance.
  • No other severe related diseases that may impact the treatment (such as other tumors, severe heart, lung and central nervous system diseases, etc.).
  • Negative pregnancy test (for female patients with fertility).
  • Male patients with fertility and female patients with fertility and pregnancy risk must agree to use contraceptive methods throughout the study period, and continued until at least 6 months after the last dose of cisplatin. Female patients do not have fertility. Female patients with postmenopausal status.

Exclusion criteria

  • Patients who have previously been diagnosed with immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related diseases.
  • Patients with a known history of active tuberculosis (TB).
  • Pregnant women or lactating women.
  • The doctors believes that it is inappropriate for patients to participate in the trial: having, for example, severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or mental illness (including recent time [within the past year] or active suicidal ideation or behavior).

Treatment and study plan

routines

Procedure

For early stage laryngeal carcinoma and hypohparyngeal carcinoma (T1 and T2), transoral laser microsurgery (CO2 laser resection), open partial laryngectomy (vertical partial laryngectomy, cricohyoidoepiglottopexy, cricohyoidopexy, horizontal partial laryngectomy), partial hypopharyngectomy, radiotherapy, and transoral robotic surgery were performed for patients with proper indications (NCCN 2020).

For advanced stage laryngeal carcinoma and hypohparyngeal carcinoma (T3 and T4), surgical treatment ± postoperative adjuvant therapy, concurrent chemoradiotherapy, neoadjuvant therapy + radiotherapy/chemoradiotherapy, or neoadjuvant therapy + surgery + radiotherapy or chemoradiotherapy were performed for patients with proper indications (NCCN 2020).

Other names: Open partial laryngectomy with laryngeal function preservation, Radiotherapy, Transoral robotic surgery, Surgical treatment ± postoperative adjuvant therapy, Concurrent chemoradiotherapy, Neoadjuvant therapy + radiotherapy/chemoradiotherapy, Neoadjuvant therapy + surgery + radiotherapy or chemoradiotherapy

Primary outcomes

  1. 3 - years overall survival

    Time frame: Three years

    the time between the treatment and the date of death from any causes

  2. 3 - years disease specific survival

    Time frame: Three years

    the time between the treatment and the date of death from laryngeal carcinoma or hypohparyngeal carcinoma

  3. 3 - years laryngeal function preservation

    Time frame: Three years

    the time between the treatment and the date of laryngeal function preservation failure

Secondary outcomes

  1. 3 - years disease free survival

    Time frame: Three years

    the time between the treatment and the first evidence of disease recurrence, metastasis or death

  2. 3- local control

    Time frame: Three years

    the time between the treatment and the first evidence of local recurrence

  3. 3- regional control

    Time frame: Three years

    the time between the treatment and the first evidence of regional recurrence

Study contacts

Contact information is provided by the study sponsor or research team.

Hongli Gong, Dr.

CONTACT

[email protected]

86 18917785176

Lei Tao, Dr.

CONTACT

[email protected]

86 2164377134

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Collaborators

  • Changhai Hospital
  • Fudan University
  • RenJi Hospital
  • Shanghai 6th People's Hospital
  • Shanghai Changzheng Hospital
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Registry information

Official study title

Department of Otorhinolaryngology, Eye & ENT Hospital

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 1, 2021
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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